Medical device market in Latin America – scope & challenges

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An analysis of medical expenditures in the major countries of Latin America (Brazil, Mexico, Colombia, Chili, Argentina, and Venezuela) with a GDP of around USD 4.25 trillion has indicated that the medical device market in the region is expected to reach around USD 24 billion in 2015, slightly lower than the expectations. This could be attributed to less favourable economic expectations in countries such as Argentina and Venezuela. Meanwhile, the e-medical market is expected to exceed USD 1.1 billion in 2015-2016. Further, the two largest markets for medical devices are found to be Brazil and Mexico with over USD 4 billion and USD 3 billion market value, respectively. Further, the report identified that the medical device distribution industry in the Latin American region is faced with several challenges such as widespread tax evasion and FCPA non-compliance, coupled with highly fragmented domestic markets with several small distribution companies. Meanwhile, regulatory approval is said to be required from the national health agencies, ANVISA and COFEPRIS, in countries such as Brazil and Mexico, respectively, for commercial use of a medical product. While the complexity of the approval process depends on the definition of risk classification, each regulatory agency has certain guidelines that define the same for each product based on the technology and the ensuing regulatory process. Moreover, pricing is said to be another challenge given the exceedingly high import and sales tariffs in countries such as Brazil.

 

(Image Courtesy: T Forg)

 

Sai Global

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